Bupropion SR for Treating Smokeless Tobacco Use
- Conditions
- Smokeless Tobacco
- Registration Number
- NCT00414180
- Lead Sponsor
- Mayo Clinic
- Brief Summary
To determine the efficacy and safety of bupropion SR for quitting tobacco in smokeless tobacco users.
- Detailed Description
CONTEXT: No pharmacotherapies have been shown to increase long-term (\≥ 6 month) tobacco abstinence rates among smokeless tobacco (ST) users, although bupropion SR has demonstrated potential efficacy in pilot studies.
OBJECTIVE: To determine the efficacy and safety of bupropion SR for tobacco abstinence among ST users compared with placebo.
DESIGN, SETTING, AND PARTICIPANTS: A randomized, double-blind, placebo-controlled trial conducted between August 2003 to May 2005 at two research centers with a 12-week treatment period and follow-up of smoking status to week 52.
INTERVENTION: Bupropion SR titrated to 150 mg twice daily or placebo for 12 weeks plus weekly behavioral interventions.
Main Outcome Measures: The primary endpoint was 7-day point-prevalence tobacco abstinence rate at week 12. Secondary outcomes included the prolonged and continuous tobacco abstinence rates at weeks 12, 24, and 52.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 225
- 18 years of age or older
- used ST daily for at least one year
- in good general health
- willing to complete all study procedures
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 7-day point-prevalence tobacco abstinence rate at week 12
- Secondary Outcome Measures
Name Time Method prolonged and continuous tobacco abstinence rates at weeks 12, 24, and 52
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States